RSV InfectionSPIRAVNCT06881953
Prevention Strategy for Respiratory Syncytial Virus (RSV) Infections in Infants in France
An observational study of RSV Infection, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Bronchiolitis is a viral lower respiratory tract infection, caused in 50 to 80% of cases by the respiratory syncytial virus (RSV). Although generally mild, RSV bronchiolitis remains the leading cause of infant hospitalizations for acute respiratory distress in Europe. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- RSV Infection
- What is being tested?
- Questionnaire
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jun 2025to 17 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women who gave birth at term in metropolitan France between October 1, 2024, and January 31 or February 2025 (i.e., during the first implementation period of the RSV-related lower respiratory infection prevention strategy for infants in metropolitan France)
Who may be able to join
- Age ≥ 18
- Able to speak and understand French well enough to read and comprehend the information leaflet and the questionnaire
- Delivery in metropolitan France between October 1, 2024, and January 31, 2025
- Live-born child
- Term-born child (37 weeks of gestation or more)
- No objection to participating in the study
Who cannot join
- Women under legal protection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Public health department, Hôpital Pitié Salpêtrière
Paris, 75013
Bénédicte COULM, RM,PhD, 01 84 82 85 34 ext. +33, benedicte.coulm@aphp.fr
About this study
Official title: Prevention Strategy for Respiratory Syncytial Virus (RSV) Infections in Infants: Maternal Vaccination During Pregnancy or Direct Immunization of Children? A French Online Study
Bronchiolitis is a viral lower respiratory tract infection, caused in 50 to 80% of cases by the respiratory syncytial virus (RSV).
Although generally mild, RSV bronchiolitis remains the leading cause of infant hospitalizations for acute respiratory distress in Europe. In France, nearly 30% of children under two years of age are affected annually, representing approximately 480,000 cases. RSV bronchiolitis accounts for 2 to 3% of hospital admissions among infants under one year each winter. These situations place a significant burden on pediatric intensive care units and emergency departments, impacting the delivery of care for other pediatric patients and raising concerns among parent and families.
Read more
Until September 2023, RSV lower respiratory tract infection prevention strategies in infants in France were limited to non-pharmacological barrier measures, with a monthly injection of the monoclonal antibody palivizumab (Synagis®) recommended among high-risk infants, particularly those born preterm before 35 weeks of gestation.
At the end of 2023, a new monoclonal antibody, nirsevimab (Beyfortus®), indicated for passive immunization in the general infant population, received marketing authorization. Administered as a single dose to neonates (from birth) and infants during their first RSV season, nirsevimab demonstrated an estimated efficacy of 76% to 83% in preventing severe RSV bronchiolitis during the 2023-2024 epidemic in France. At the same time, the RSV vaccine Abrysvo® (Pfizer) became available in France since September 2024, following European marketing authorization in August 2023. Administered during the third trimester of pregnancy, this maternal immunization strategy aims to confer passive immunity to neonates (from birth up to six months of age) through transplacental transfer of RSV-specific maternal antibodies.
For the 2024-2025 RSV season, the national prevention strategy for RSV-related respiratory infections in infants is based on general non-pharmacological measures and, between September 15, 2024, and January 31, 2025, on maternal vaccination (administered between 32 and 36 weeks of gestation) and/or direct administration of nirsevimab to neonates.
To date, no population-based data are available in France regarding maternal adherence to the current RSV prevention strategy for respiratory syncytial virus (RSV) infections in infants. The acceptability of maternal RSV vaccination remains unknown, as well as the factors associated with the choice between the two recommended strategies and the reasons given by pregnant women for their decision.
The objective of this study is to assess, in population, the adherence of pregnant women to the current RSV infection prevention strategy for infants in France, which has not yet been studied. The study will focus on the method most commonly chosen by women (maternal vaccination with Abrysvo® during pregnancy or administration of nirsevimab (Beyfortus®) to their neonates), aiming to identify the factors associated with the choice of one strategy over the other and to describe the main reasons women give for their decision to either follow or not follow one of the prevention strategies.
- Conditions
- RSV Infection
- Being tested
- Questionnaire
- Keywords
- Respiratory syncytial virus, nirsevimab, vaccine, health campaign
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
The questionnaire will be completed on line by the participants (approx. 10 min).
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence of pregnant women to the current RSV infection prevention strategy for infants in France.
The primary aim of this study is to assess the adherence of pregnant women to the current RSV infection prevention strategy for infants in France, defined as the administration of the RSV vaccine Abrysvo® during pregnancy and/or the direct administration of specific monoclonal antibodies (nirsevimab, Beyfortus®) to the neonate.
Measured: Through study time period, 6 months
Secondary outcomes (3)
Assessing the factors associated with overall adherence to this prevention strategy.
Through online questionnaire
Measured: Through study time period, 6 months
Identifying and assessing the maternal and organizational factors associated with the choice of maternal vaccination or administration of nirsevimab to the neonate.
Through online questionnaire
Measured: Through study time period, 6 months
Describing the main reasons reported by women to explain their decision to follow or not follow one of the prevention strategies.
Through online questionnaire
Measured: Through study time period, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start17 Jun 2025
- Primary completion17 Dec 2025 (estimated)
- Study completion17 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RSV InfectionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06881953
- Sponsor's protocol ID
- APHP250429
- Acronym
- SPIRAV
- Status last verified
- Mar 2025
- First submitted
- 11 Mar 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data are available upon reasonable request The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention Strategy for Respiratory Syncytial Virus (RSV) Infections in Infants: Maternal Vaccination During Pregnancy or Direct Immunization of Children? A French Online Study
- ClinicalTrials.gov ID
- NCT06881953
- Acronym / sponsor ID
- SPIRAV / APHP250429
- Conditions
- RSV Infection
- Keywords
- Respiratory syncytial virus, nirsevimab, vaccine, health campaign
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 17 Jun 2025 (actual)
- Primary completion
- 17 Dec 2025 (estimated)
- Study completion
- 17 Dec 2025 (estimated)
- First posted
- 18 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bronchiolitis is a viral lower respiratory tract infection, caused in 50 to 80% of cases by the respiratory syncytial virus (RSV).
Although generally mild, RSV bronchiolitis remains the leading cause of infant hospitalizations for acute respiratory distress in Europe. In France, nearly 30% of children under two years of age are affected annually, representing approximately 480,000 cases. RSV bronchiolitis accounts for 2 to 3% of hospital admissions among infants under one year each winter. These situations place a significant burden on pediatric intensive care units and emergency departments, impacting the delivery of care for other pediatric patients and raising concerns among parent and families.
Until September 2023, RSV lower respiratory tract infection prevention strategies in infants in France were limited to non-pharmacological barrier measures, with a monthly injection of the monoclonal antibody palivizumab (Synagis®) recommended among high-risk infants, particularly those born preterm before 35 weeks of gestation.
At the end of 2023, a new monoclonal antibody, nirsevimab (Beyfortus®), indicated for passive immunization in the general infant population, received marketing authorization. Administered as a single dose to neonates (from birth) and infants during their first RSV season, nirsevimab demonstrated an estimated efficacy of 76% to 83% in preventing severe RSV bronchiolitis during the 2023-2024 epidemic in France. At the same time, the RSV vaccine Abrysvo® (Pfizer) became available in France since September 2024, following European marketing authorization in August 2023. Administered during the third trimester of pregnancy, this maternal immunization strategy aims to confer passive immunity to neonates (from birth up to six months of age) through transplacental transfer of RSV-specific maternal antibodies.
For the 2024-2025 RSV season, the national prevention strategy for RSV-related respiratory infections in infants is based on general non-pharmacological measures and, between September 15, 2024, and January 31, 2025, on maternal vaccination (administered between 32 and 36 weeks of gestation) and/or direct administration of nirsevimab to neonates.
To date, no population-based data are available in France regarding maternal adherence to the current RSV prevention strategy for respiratory syncytial virus (RSV) infections in infants. The acceptability of maternal RSV vaccination remains unknown, as well as the factors associated with the choice between the two recommended strategies and the reasons given by pregnant women for their decision.
The objective of this study is to assess, in population, the adherence of pregnant women to the current RSV infection prevention strategy for infants in France, which has not yet been studied. The study will focus on the method most commonly chosen by women (maternal vaccination with Abrysvo® during pregnancy or administration of nirsevimab (Beyfortus®) to their neonates), aiming to identify the factors associated with the choice of one strategy over the other and to describe the main reasons women give for their decision to either follow or not follow one of the prevention strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women who gave birth at term in metropolitan France between October 1, 2024, and January 31 or February 2025 (i.e., during the first implementation period of the RSV-related lower respiratory infection prevention strategy for infants in metropolitan France)
Key inclusion criteria (6 listed)
- Age ≥ 18
- Able to speak and understand French well enough to read and comprehend the information leaflet and the questionnaire
- Delivery in metropolitan France between October 1, 2024, and January 31, 2025
- Live-born child
- Term-born child (37 weeks of gestation or more)
Key exclusion criteria (1 listed)
- Women under legal protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireThe questionnaire will be completed on line by the participants (approx. 10 min). | Other | – |
Primary outcome
Adherence of pregnant women to the current RSV infection prevention strategy for infants in France.
Time frame: Through study time period, 6 months
The primary aim of this study is to assess the adherence of pregnant women to the current RSV infection prevention strategy for infants in France, defined as the administration of the RSV vaccine Abrysvo® during pregnancy and/or the direct administration of specific monoclonal antibodies (nirsevimab, Beyfortus®) to the neonate.
3 secondary outcomes
Assessing the factors associated with overall adherence to this prevention strategy.
Time frame: Through study time period, 6 months
Identifying and assessing the maternal and organizational factors associated with the choice of maternal vaccination or administration of nirsevimab to the neonate.
Time frame: Through study time period, 6 months
Describing the main reasons reported by women to explain their decision to follow or not follow one of the prevention strategies.
Time frame: Through study time period, 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Individual participant dataSharing planned: Yes. Data are available upon reasonable request The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
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RSV
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of RSV Infection, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bénédicte COULM, RM,PhD (01 84 82 85 34, benedicte.coulm@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence of pregnant women to the current RSV infection prevention strategy for infants in France. (time frame: Through study time period, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.